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NCT Number: NCT02098382

Dilapan-S Osmotic Dilator in Pre-induction of Labor

Non-interventional prospective data collection designed to evaluate clinical outcome on the efficacy of the use of Dilapan-S in the indication of labor pre-induction in women with/without a history of Caesarean section. The evaluation will be based on prospective data collection in at least four obstetrics centers in the Czech Republic.

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Key information

Conditions

Uterine Cervical Incompetence Abortion, Habitual Abortion, Spontaneous Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Pregnancy Complications Urogenital Diseases Uterine Cervical Diseases Uterine Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Clinic of Gynecology&Obstetrics, University hospital in Brno and Masaryk University Medical School

Brno, 625 00, Czechia

About this study

Nowadays there is a rising need for non-pharmacological cervical ripening methods as the use of prostaglandins is frequently limited by various contraindications. Dilapan-S is a hygroscopic uterine neck dilator. Its mode of action consists in the hydrophilic properties of the device absorbing fluids from surrounding tissue structures, thus expanding the volume of Dilapan-S sticks which subsequently exert radial pressure on the surrounding structures (uterine neck) to dilate progressively. Endocervical pressure on the uterine neck results not only in its mechanical dilatation but pressure on endocervical structures also stimulates the production of endogenous prostaglandins, which promote cervical ripening through its collagenolytic action. Although Dilapan-S is widely used in labor pre-induction, published study data comparing its clinical efficacy and safety in females with/without caesarean section in medical history are lacking.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Single pregnancy
  • Pregnancy more than 36 weeks
  • Vertex presentation of the fetus
  • Cervix Score less than 4 points

Exclusion criteria

  • Contraindication to vaginal delivery
  • Pathological fetal station
  • States after uterine body surgery - except for Caesarean section
  • Clinical signs of uterine, vaginal or vulvar infection
  • Fetus hypoxia (KTG recording evaluated as pathological prior to pre-induction initiation)

Treatment and study plan

Dilapan-S

Device

Dilapan-S synthetic osmotic dilator for cervical ripening prior to labor induction

Other names: synthetic osmotic dilator

Primary outcomes

  1. Cervix (Bishop) score

    Time frame: Before pre-induction of labor performance and up to 24 h after pre-induction of labor

    To evaluate, based on the value obtained in the Cervix Score, the efficacy of use of the Dilapan-S device in the indication labor pre-induction, and to compare outcomes in patients with/without a history of Caesarean section.

Secondary outcomes

  1. Total duration of pre-induction

    Time frame: From Dilapan-S rods insertion up to 24 hours

    To compare these outcomes in patients with and without a history of Caesarean section.

  2. Number of dilators inserted

    Time frame: At the moment of Dilapan-S insertion up to 24 hours until their removal

    Expected the insertion from 2 to 5 Dilapan-S rods. To compare these results in patients with/without Cesarean section in their medical history.

  3. Uterine contractions

    Time frame: From Dilapan-S rods insertion up to 24 h during pre-induction of labor phase

    To compare these results in patients with/without Caesearean section in their medical history. Uterine hypertonus is diagnosed, when the number of uterine contractions is higher than 5 within 10 minutes (during pre-induction).

  4. The course of delivery (vaginally or Caesarean section)

    Time frame: From active phase of labor up to 1 day after delivery

    To compare the rate of vaginal delivery/Caesarean sections in patients with/without Caesarean section in their medical history.

  5. Apgar score

    Time frame: At 1st, 5th and 10th minute after delivery

    To compare these results in patients with/without Caesarean section in their medical history.

  6. pH of the fetus

    Time frame: Up to 10 minutes after delivery

    To compare the results in patients with/without caesarean section in their medical history. The rate of ceses with pH below 7,1.

  7. Infection complications of mother / fetus

    Time frame: Up to 5 days from the birth

    Clinical signs of infection are defined as follows:

    • CRP levels > 8 mg/l
    • Leukocyte count > 18 x 109/l
    • Body temperature > 37.5°C

Other outcomes

  1. Course of removal of Dilapan-S rods after pre-induction

    Time frame: At the moment of removal of Dilapan-S rods after labor pre-induction phase up to 1 day after delivery

    The evaluation of the course of removal of Dilapan-S after termination of preinduction by physician as very easy, easy, standard, with some complications or very complicated.

  2. Occurance of complication of rupture of fetal sac due to the use of Dilapan-S or other complications related to the use of Dilapan-S

    Time frame: From Dilapan-S rods insertion up to 24 h of duration of labor pre-induction phase

  3. Patients´evaluation of pre-induction of labor with Dilapan-S

    Time frame: From Dilapan-S insertion up to 24 h of duration of labor pre-induction phase

    Subjective satisfaction Pain experienced during Dilapan-S insertion and pre-induction phase Quality of relax and sleep Frequency and intensity of uterine contractions during pre-induction

Sponsors and collaborators

Lead sponsor

Medicem International CR s.r.o.

Industry

Registry information

Official study title

Prospective Collection of Data About the Use of the Dilapan-S Osmotic Dilator in Pre-induction of Labor in Women With/Without Caesarean Section in Their History

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Mar 28, 2014
Registry last updated
Jul 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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